25 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PULLUP® Adjustable Juxtacortical Fixation Device
FDA 510(k)
FDA Class 2
·Orthopedic
AGXO
FDA UDI
Oticon A/S·05707131282637·H110V2, BTE 13 WL 85 CBE AGXO
AGC Tradition Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304008267·
Combifix™
FDA UDI
MEDTEC, INC.·00841439109946·baseplate with (2) elevation blocks, Feetfix™ b...
BrightGear Headgear
FDA UDI
ORMCO CORPORATION·00889989079906·PAD, CERVICAL BLUE
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613053406·Red AutoClavable Surgical Identification Tape, ...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306830808·Instrument ID Tape, Red, Roll 6.35mm x 762cm
Engage Partial Knee System
FDA UDI
Engage UNI LLC·B6951510040050·Distal Cutting Guide Long, Left Medial
Engage Partial Knee System
FDA UDI
Engage UNI LLC·B6951510040000·Distal Cutting Block Left Medial
CHARNLEY OGEE CUP 22.225/40MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·February 13, 2004
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 25, 2025
HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ATLANTIS ABUTMENT FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT
FDA 510(k)
FDA Class 2
·Dental
UniTip Catheter
FDA UDI
Unisensor AG·07640172973226·
Engage Partial Knee System
FDA UDI
Engage UNI LLC·B695151004000A0·Distal Cutting Block Left Medial
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 6, 2013
UNKNOWN DEPUY FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWY·June 30, 2011
LS PLUMSET-OL DUAL W/CLAVE & 0.2MICRON FILTER
FDA Adverse Event
Malfunction
·HOSPIRA DE COSTA RICA LTD.·Product code FPA·August 28, 2008
Biograph mMR. Model Number: 10433372.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 26, 2014